Longeveron to Present at the Annual Dawson James Small Cap Growth Conference

MIAMI, Oct. 05, 2022 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today that Chris Min, M.D., Ph.D., Interim Chief Executive Officer, and Chief Medical Officer at Longeveron, will present at the upcoming Dawson James Small Cap Growth Conference taking place in Jupiter, Florida from October 11-12, 2022.

Longeveron’s presentation will take place on Wednesday, October 12, 2022 from 4:30 – 4:55 p.m. ET. A live webcast of the presentation can be accessed by visiting “Events & Presentations” in the Investors section of Longeveron’s website at https://www.longeveron.com/. A replay of the webcast will be available shortly following the conference.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has a multi-modal mechanism of action that is pro-vascular, pro-regenerative, and anti-inflammatory, promoting tissue repair and healing with broad potential applications across a spectrum of disease areas. Longeveron is advancing Lomecel-B™ through clinical trials in three indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer’s Disease, and Aging Frailty. Additional information about the Company is available at www.longeveron.com.

Investor Contact:

Elsie Yau
Stern IR, Inc.
212-698-8700
[email protected]  



Verizon lands $1.58B Task Order from Dept. of State to modernize U.S. embassies

Enterprise Infrastructure Solutions (EIS) task order means Verizon will upgrade technology and network infrastructure for embassies in nearly 260 locations across the globe

WASHINGTON, Oct. 05, 2022 (GLOBE NEWSWIRE) — Verizon announced a new Enterprise Infrastructure Solutions (EIS) contract to modernize the global communications infrastructure and provide IT services for each of the Department of State’s (DOS) U.S. embassies, consulars, and other key locations around the globe.

The contract, worth $1.58 billion over the next 10 years, includes implementation and management of network solutions for the Department’s non-domestic footprint, including Asia, Africa, the Middle East and South America.

“We are uniquely qualified to provide the Department of State with powerful solutions to their global network consolidation and management needs,” said Maggie Hallbach, Senior Vice President, Public Sector at Verizon. “We have supported the Department of Defense and other national security and civilian customers with global critical infrastructure and communications for more than three decades.”

The contract includes a proven management approach using experienced Verizon Public Sector teams, clear processes and technology-enabled tools to deliver all service on time and according to service performance standards.

Verizon Public Sector has been a market leader in capturing EIS task orders from the federal government, including recent wins with the Federal Bureau of Investigation and the U.S. Department of Defense.

Verizon Communications Inc. (NYSE, Nasdaq: VZ) was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control.

VERIZON’S ONLINE MEDIA CENTER: News releases, stories, media contacts and other resources are available at verizon.com/news. News releases are also available through an RSS feed. To subscribe, visit www.verizon.com/about/rss-feeds/.

Media contact:

Geoffrey Basye
[email protected]
(202) 748-1882



Acer Therapeutics Announces Expansion of ACER-801 (osanetant) Development Indications to Include Post-Traumatic Stress Disorder

Licensed exclusive worldwide rights from Emory University to patents and patent applications for certain methods of treating or preventing post-traumatic stress disorder (PTSD) with osanetant

Osanetant targets a distinct group of brain cells in a region of the brain that controls the formation and consolidation of fear memories
, which may aid in preventing PTSD

1

Up to 20% of people who have experienced a traumatic event will develop PTSD

2

leading to over
12 million adults in the US suffering from PTSD during a given year

3

NEWTON, Mass., Oct. 05, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious, rare and life-threatening diseases with significant unmet medical needs, today announced the expansion of ACER-801 (osanetant) into a new indication, for the reduction of the frequency and severity of acute stress disorder and post-traumatic stress disorder (PTSD). Acute stress disorder refers to the body’s immediate response to trauma, whereas PTSD is defined as the long-term effects of trauma.

Studies conducted at Emory University screened thousands of genes that were activated in the brains of mice following fear conditioning events. The top gene identified was Tac2, which is responsible for the production of the peptide, Neurokinin B (NKB), in mice. The researchers showed that the Tac2 gene, expressed by neurons specifically within the amygdala, is required for modulating fear memories, and that NKB, and its specific receptor, NK3R, are also involved in the consolidation of fear memories. By administering the potent and specific NK3R antagonist, osanetant, they were able to block fear memory consolidation shortly after exposure to a trauma, potentially providing a novel therapeutic approach for disorders with altered fear learning such as PTSD.1

“Immediately – hours to several days – after trauma exposure, memory remains in a labile state, called the memory consolidation period, and blocking fear memory consolidation after trauma exposure could lower the frequency and severity of PTSD in trauma patients,” said Kerry Ressler, MD, PhD, Chief Scientific Officer and James and Patricia Poitras Chair in Psychiatry at McLean Hospital.

“Activation of the NK3 receptor pathway in the central amygdala is necessary and sufficient for the modulation of fear memories, and we have learned that by blocking this pathway with osanetant, we can block the consolidation of fear memories in animal models,”1 added Dr. Ressler. “Osanetant is a promising agent that could reduce the frequency and of severity of PTSD for millions of people who experience a traumatic event.”

Acer previously entered into an agreement with Emory for an exclusive world-wide license to US Patent No. 10,314,835, US Application 15/320,952, and European Patent No. EP3160469 covering certain methods of treating or preventing PTSD with osanetant. 

“We are pleased to further expand our ACER-801 development program into PTSD, an increasingly prevalent psychiatric disorder that affects millions every year. Today’s announcement further validates Acer’s strategy of identifying and developing treatments based on promising technology that can be applied in new ways for use in diseases with high unmet need,” commented Chris Schelling, CEO and Founder of Acer Therapeutics. “While the role of the NK3R pathway in the hypothalamus to manage thermoregulation is well-established in clinical trials, this opportunity explores an entirely different mechanism of action for the drug. We look forward to presenting our clinical development plan for ACER-801 for the reduction of frequency and severity of PTSD in the near future.”

According to the National Center for PTSD, in the US about 6 of every 10 men (or 60%) and 5 of every 10 women (or 50%) experience at least one trauma in their lives leading to about 12 million adults in the U.S. have PTSD during a given year.3 In the US alone, one-third of emergency department visits are for evaluation after trauma exposures and up to 20% of people who have experienced a traumatic event will develop PTSD.4

Rationale for ACER-801 (osanetant) Evaluation in Post-Traumatic Stress Disorder.
The Tacr3 gene encodes tachykinin receptor 3 (NK3R), which belongs to the tachykinin receptor family. This family of proteins includes typical G protein-coupled receptors and belongs to the rhodopsin subfamily. NK3R functions by binding to its high-affinity ligand, Neurokinin B (NKB), which is encoded by the Tac3 (human) gene. The role of NKB-NK3R in growth and reproduction has been extensively studied, but NKB-NK3R is also widely expressed in the nervous system from the spinal cord to the brain and is involved in both physiological and pathological processes in the nervous system.5 In animal models, Tac2 (mice) mRNA levels are rapidly up-regulated during fear consolidation 30 minutes after fear conditioning, and subsequent NKB-NK3R activation can lead to over stress sensitization and the consolidation of fear,6 and treatment with osanetant has been shown to block a critical fear/stress sensitization step in the brain.1,7,8 An effective therapeutic to reduce acute and persistent/long-term psychological and somatic symptoms would fulfill a large unmet need.

About Acer Therapeutics

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four investigational programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS) and post-traumatic stress disorder (PTSD); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of viruses, including cytomegalovirus, Zika, dengue, Ebola and COVID-19. For more information, visit www.acertx.com.

References

  1. Andero R, Dias BG, Ressler KJ. A role for Tac2, NkB, and Nk3 receptor in normal and dysregulated fear memory consolidation. Neuron. 2014;83(2):444-454
  2. Sidran Institute. Traumatic Stress Education & Advocacy Fact Sheet.
  3. National Center for PTSD. How Common is PTSD in Adults?
  4. Sidran Institute. Traumatic Stress Education & Advocacy Fact Sheet.
  5. Zhang et al. Tacr3/NK3R: Beyond Their Roles in Reproduction. ACS Chemical Neuroscience 2020 11 (19), 2935-2943
  6. Al Abed et. Al, Biological Psychiatry 2021
  7. Andero R, Daniel S, Guo JD, et al. Amygdala-Dependent Molecular Mechanisms of the Tac2 Pathway in Fear Learning. Neuropsychopharmacology. 2016;41(11):2714-2722
  8. Zelikowsky M, Ding K, Anderson DJ. Neuropeptidergic Control of an Internal Brain State Produced by Prolonged Social Isolation Stress. Cold Spring Harb Symp Quant Biol. 2018;83:97-103

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, statements about the role we believe ACER-801 could play in reducing the frequency and severity of PTSD, the planned clinical evaluation of ACER-801 for such indication, and the continued development of ACER-801 for treatment of iVMS. Our pipeline products (including ACER-801) are under investigation and their safety and efficacy have not been established and there is no guarantee that any of our investigational products in development will receive health authority approval or become commercially available for the uses being investigated. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the availability of financing to fund our pipeline product development programs and general corporate operations as well as risks related to drug development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You may access these documents for no charge at http://www.sec.gov.

Acer Contacts

Corporate contact:
Jim DeNike
Acer Therapeutics Inc.
[email protected]
+1-844-902-6100

Investor contact:
Nick Colangelo
Gilmartin Group
[email protected]
+1-332-895-3226



SonicShares™ Global Shipping ETF (NYSE Arca: BOAT) Pays Quarterly Dividend

MIDDLETOWN, Del., Oct. 05, 2022 (GLOBE NEWSWIRE) — The SonicShares™ Global Shipping ETF (NYSE Arca: BOAT) (the “Fund”) recently paid a quarterly dividend. Please see details of recent dividend in the table below.

Dividend
per Share
Current
Yield*
30-Day SEC
Yield**
Ex-Date Record
Date
Payment
Date
$1.0700 17.80% 12.39% 9/28/2022 9/29/2022 9/30/2022

Fund’s Dividend History

Payment Date Dividend per Share
9/30/2022 $1.0700
6/30/2022 $1.2734
3/31/2022 $0.7780
12/31/2021 $0.3520
9/27/2021 $0.0520^

^ The Fund’s inception date is August 3, 2021.

The Fund provides investors with pure play exposure to a portfolio of global companies engaged in maritime shipping. For more information about the Fund and standardized Fund performance, please visit: http://www.sonicshares.com/BOAT.

The performance data quoted above represents past performance. Past performance does not guarantee future results. The investment return and principal value of an investment will fluctuate so that an investor’s shares, when sold or redeemed, may be worth more or less than their original cost and current performance may be lower or higher than the performance quoted above. Performance current to the most recent month-end can be obtained by calling 
(833) 378-0717
.


Investors should consider the investment objectives, risks, charges and expenses carefully before investing. For a prospectus of the Fund, 



click here



. Read the prospectus or summary prospectus carefully before investing.

Dividends are not guaranteed. Investing involves risk. Loss of principal is possible.

Fund Risks: An investment in the Fund is subject to numerous risks including the possible loss of principal. There can be no assurance that the Fund will achieve its investment objective.  Equity securities, such as common stocks, are subject to market, economic and business risks that may cause their prices to fluctuate. As with all ETFs, Fund shares may be bought and sold in the secondary market at market prices. The market price normally should approximate the Fund’s net asset value per share (NAV), but the market price sometimes may be higher or lower than the NAV. The Fund is new with a limited operating history. There are a limited number of financial institutions authorized to buy and sell shares directly with the Fund, and there may be a limited number of other liquidity providers in the marketplace. There is no assurance that Fund shares will trade at any volume, or at all, on any stock exchange. Low trading activity may result in shares trading at a material discount to NAV. Please see the prospectus and summary prospectus for a complete description of principal risks.

The Fund’s investments will be concentrated in an industry or group of industries to the extent the Index is so concentrated. In such event, the value of Shares may rise and fall more than the value of shares that invest in securities of companies in a broader range of industries.  Investments in securities or other instruments of foreign securities involve certain risks not involved in domestic investments and may experience more rapid and extreme changes in value than investments in securities of U.S. companies.

Companies in the transportation industry, including companies engaged in the water transportation industry, may be adversely affected by economic changes, increases in fuel, operating and insurance costs and adverse labor relations.


*

The Current Yield equals the Dividend per Share, multiplied by four (to annualize such amount), divided by the Fund’s closing NAV on 9/30/2022.


**

The 30-Day SEC Yield represents net investment income earned by the Fund over the 30-Day period ended 9/30/2022, expressed as an annual percentage rate based on the Fund’s share price at the end of the 30-Day period. The 30-Day unsubsidized SEC Yield does not reflect any fee waivers, reimbursements, or limits in effect.

The fund is distributed by Foreside Fund Services, LLC.

Opinions expressed herein are subject to change and should not be considered investment advice.

The “SonicShares” mark and the SonicShares logo are trademarks of Lucania Investments LLC (the “Licensor”). The Licensor and its affiliates are not affiliated with the Fund’s Adviser, any Sub-Adviser, Index Provider, Trust, administrator, custodian, transfer agent, distributor, or any of their respective affiliates. The Licensor and its affiliates have no role in the administration or operation of the Fund, nor do they make investment decisions, provide investment advice, or otherwise act in the capacity of an investment adviser to the Fund. The Fund is not sold by the Licensor or any of its affiliates. The Licensor and its affiliates make no representation, condition or warranty, express or implied, to the owners of the Fund or any member of the public regarding the advisability of investing in securities generally or in the Fund particularly.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3de412d3-8bb6-42f7-a734-c7232b147a73



[email protected] or (833) 378-0717

Fluent Launches Purpose to Empower Consumer Financial Decisions

Company Hires Industry Veteran to Further Consumer Value with Financial Wellness App

NEW YORK, Oct. 05, 2022 (GLOBE NEWSWIRE) — Fluent, Inc. (NASDAQ: FLNT), a leading data-driven performance marketing company, announced the launch of Purpose, a mobile app focused on enabling consumer financial decisions and wellness through content and brand discovery. Ari Kassman, an entrepreneur with deep experience building technology companies, will join Fluent to help grow Purpose and develop other community-driven products.

Purpose advances financial wellness, literacy, and education while saving consumers money. A complimentary addition to Fluent’s existing media portfolio and rewarded discovery capabilities, Purpose matches consumers to brands through engaging content and relevant services that align to their lifestyle, budget and values.

“Creating quality, relevant experiences sits at the core of Fluent’s consumer-centric strategy,” said Ryan Schulke, Chief Strategy Officer and Co-Founder of Fluent. “With the launch of Purpose, we empower people to improve their financial wellness and grow their savings during a turbulent economic time. I am excited to have Ari join our executive team, focused on product strategy and development to enable new ways of creating value for consumers and our brand partners.”

Ari Kassman joins the team to grow Purpose’s reach and scale by leveraging Fluent’s performance marketing platform. Ari will be focused on strategic growth initiatives to support consumer engagement and loyalty. Ari comes to Fluent with a successful track record of launching businesses with high-growth trajectories, with acquisitions of two of his companies by two industry-leading organizations. Prior to Fluent, Ari was Co-Founder of Open Mail (now System1) and Founder / Owner of Active Response Group (now Zeta Global).

“Purpose is built around a community of hard-working members striving to grow their savings and more efficiently navigate life’s important decisions,” said Ari Kassman. “Fluent’s ability to cultivate relevant, targeted consumer experiences is an unmatched growth engine for service categories, especially financial wellness.”

The launch of Purpose and addition of Ari Kassman to the Fluent team are the most recent strategic moves the company is making to provide consumers more value, while focusing on its ongoing growth trajectory.

About Fluent, Inc. 
Fluent, Inc. (NASDAQ: FLNT) is a global data-driven performance marketing company and trusted growth partner for leading brands. Experts in creating value for consumers, Fluent leverages its consumer database, digital media portfolio, and proprietary data science and technology to deliver outcome-based solutions for marketers. Founded in 2010, the company is headquartered in New York City.

Forward-Looking statements

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipate,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward looking statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. Readers are also advised to consider the factors under the heading “Forward-Looking Statements” and “Risk Factors” in the Company’s Annual Report on Form 10-K, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q and other SEC filings. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contact Information 

Media Relations
Fluent, Inc.
[email protected] 



Nauticus Robotics, Inc. Announces Additional Contract Award with U.S. Defense Innovation Unit for an Autonomous Amphibious Robot

HOUSTON, Oct. 05, 2022 (GLOBE NEWSWIRE) — Nauticus Robotics, Inc. (“Nauticus” or “Company”) (NASDAQ: KITT), a developer of autonomous ocean robots and associated services, announced today that it has been awarded a second multi-million dollar contract by the U.S. Defense Innovation Unit (“DIU”) for the development of an amphibious unmanned system also utilizing the Company’s autonomous command and control software platform, ToolKITT. This development follows Nauticus’ previous DIU award announcement on February 15, 2022, where ToolKITT is being utilized aboard the U.S. Navy’s Defender Mission Specialist remotely operated vehicle systems to advance the subsea vehicle with more autonomous behaviors. DIU is a Department of Defense organization that contracts with commercial companies to solve national security problems.

Nauticus developed its proprietary ToolKITT autonomy platform over years of internal investments and advancements sponsored by government agencies and commercial customers. ToolKITT is a unified software platform utilizing advances in machine learning to identify, classify, and perform complex underwater activities, which can be applied to remove, detect, identify, inspect, and neutralize hazards underwater. ToolKITT was specifically designed to enable autonomous actions across multiple robotics platforms and is also used in Nauticus’ flagship product, Aquanaut.

“We are thrilled with the additional work the DIU and the U.S. Marine Corps have awarded us to continue providing leading maritime robotics and autonomy solutions to assist the warfighter,” said Ed Tovar, Director of Business Development for Defense Systems at Nauticus. “We are humbled and honored to be doing our part to advance the usage of robotics and autonomous systems to remove servicemembers from harm’s way.”

This competitively awarded prototype project has the potential of follow-on production contracts without further competition, in accordance with §10 U.S.C. 2371b(f), and upon a determination that the prototype project has successfully been completed.

About Nauticus

Nauticus Robotics, Inc. is a developer of autonomous ocean robots and associated services. Nauticus’ robotic systems and services are delivered to government agencies and commercial customers through a Robotics-as-a-Service (RaaS) business model and direct product sales. Besides a standalone service offering and products, Nauticus’ approach to ocean robotics has also resulted in the development of a range of technology products for retrofitting/upgrading legacy systems and other third-party vehicle platforms. Nauticus provides customers with the necessary data collection, analytics, and subsea manipulation capabilities to support and maintain assets while reducing their operational footprint, operating cost, and greenhouse gas emissions, to improve offshore health, safety, and environmental exposure.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included in this press release, are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon current expectations, estimates, projections, and assumptions that, while considered reasonable by Nauticus and its management, are inherently uncertain; factors that may cause actual results to differ materially from current expectations include, but are not limited to: 1) the outcome of any legal proceedings that may be instituted against Nauticus or others following the closing of the business combination; 2) Nauticus’ ability to meet the Nasdaq Stock Market LLC’s listing standards following the consummation of the Business Combination; 3) the risk that the Business Combination disrupts current plans and operations of Nauticus as a result of consummation of the Business Combination; 4) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees; 5) costs related to the Business Combination; 6) changes in applicable laws or regulations; 7) the possibility that Nauticus may be adversely affected by other economic, business and/or competitive factors, including the impacts of the COVID-19 pandemic, geopolitical conflicts, such as the conflict between Russia and Ukraine, the effects of inflation and potential recessionary conditions; and 8) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in CLAQ’s Registration Statement on Form S-4, as amended, filed with the SEC, and other documents of CLAQ and Nauticus filed, with the SEC. Although Nauticus believes the expectations reflected in the forward-looking statements are reasonable, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward looking statements will be achieved. There may be additional risks that Nauticus presently does not know of or that Nauticus currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements, many of which are beyond Nauticus’ control. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Nauticus does not undertake, and expressly disclaims, any duty to update these forward-looking statements, except as otherwise required by applicable law.

For investor and media inquiries, please contact:

Investors Relations Contact

Cody Slach or Jeff Grampp, CFA
Gateway Group, Inc.
(949) 574-3860
[email protected]

Media Contact

Zach Kadletz
Gateway Group, Inc.
(949) 574-3860
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9b372409-6e27-4973-84ff-2e5361ba4622



Agenus to Host “The Road Taken” R&D Event on November 12, 2022

LEXINGTON, Mass., Oct. 05, 2022 (GLOBE NEWSWIRE) — Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced it will host an in-person and virtual Research & Development event (“The Road Taken”) on Saturday, November 12, 2022, from 2:00 p.m. to 5:00 p.m. ET at the Prudential Tower in Boston, MA.

The Road Taken will feature both key opinion leaders at the forefront of immunotherapy development for cancer and Agenus’ expanding leadership team. During the event, speakers will highlight recent developments within the Agenus clinical-stage pipeline of novel immunotherapy programs, study details involving botensilimab, a multi-functional Fc-enhanced anti-CTLA-4 which activates innate and adaptive immune responses, opportunities to combine Agenus pipeline assets to overcome immuno-oncology resistance and strategies to reach commercialization as rapidly as possible.

Featured speakers will include:

  • Michael Atkins, MD, Deputy Director & Professor, Acting Chief, Division of Hematology/Oncology MedStar Georgetown University Hospital; SITC 2022 Lifetime Achievement Award Recipient
  • Breelyn Wilky, MD, Director of Sarcoma Medical Oncology, Deputy Associate Director for Clinical Research University of Colorado Medicine; Principal Investigator/Presenter C-800 Study
  • Steven O’Day, MD, Chief Medical Officer, Agenus
  • Joseph Grossman, MD, VP and Head of Exploratory Medicines, Agenus
  • Patricia Carlos, Chief Regulatory, Quality, and Safety Officer, Agenus

The scientific program will take place from 2:00 p.m. to 4:00 p.m. ET and will be followed by a reception from 4:00 p.m. to 5:00 p.m. ET.

The event will be webcast live and institutional investors and research analysts are invited to attend in person. Individuals interested in attending the event in person should contact Agenus Investor Relations at [email protected]. The webcast will be available on the Investors section of the Agenus website at investor.agenusbio.com. To register for the webcast, please click here. Following the webcast, an archived version will be available on the Agenus website.

About Agenus

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. The Company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to our technologies, therapeutic candidates, and capabilities, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety and tolerability profile of our therapeutic candidates, both alone and in combination with each other and/or other agents; statements regarding future plans, including research, clinical, regulatory, and commercialization plans; and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission and available on our website: www.agenusbio.com. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.


Contact

Ethan Lovell

Chief External Affairs & Communications Officer

339-927-1763

[email protected]



ToughBuilt Industries Secures New Distributor Agreements with Four Major Retailers in Germany

IRVINE, Calif., Oct. 05, 2022 (GLOBE NEWSWIRE) — Today, ToughBuilt Industries, Inc. (“ToughBuilt”) (NASDAQ: TBLT; TBLTW) announced it has entered into four major retailers in Germany, representing tens of thousands of new end users across Europe, which accounted for a 35% share of the global hand tools market in 2022.1 A wide range of ToughBuilt SKUs will now be sold in stores and online by these new retailers:  

  • Friedrich Delker GmbH & Co. KG (“

    Delker

    ”). Delker is one of the largest privately owned hardware suppliers in Germany. With three general headquarters across Germany and Poland and a strong e-commerce presence, Delker is a professional wholesale group selling power tools, warehouse and factory equipment, machine tools, and occupational safety products from globally recognized brands. 

  • Witte Metallwaren GmbH & Co.KG (“

    Witte

    ”)

    .
    Witte supplies flooring, interior specialists, painters, and floor covering wholesalers and continues to be under family ownership today. All new additions to its portfolio of brands are subjected to a stringent round of quality testing to ensure they meet Witte’s exacting standards. 

  • Vageler & Christiansen GmbH (“

    Vageler & Christiansen

    ”). A major online retailer, Vageler & Christiansen distributes tools, machines, protective clothing, and accessories to professional consumers across Europe. The business ships over 2,500 orders monthly to over 30,000 end users.

  • Bernd Ulbricht Nachf, A supplier of professional customers with tools and consumables (such as fixings and fastenings), building chemicals, and workshop supplies from its headquarters in Großolbersdorf, is an established source of quality for the Saxon community.

Michael Panosian, ToughBuilt CEO, commented, “These new partnerships in Germany offer the Company opportunities to capture further market share in a key EU Member state for ToughBuilt’s global growth strategy and European expansion. Our distribution alliance with Witte, Bernd Ulbricht Nachf, and Delker will help to increase awareness of the ToughBuilt brand, cementing our reputation for quality and innovation worldwide.” 

  1. COHERENT MARKET INSIGHTS 2022, (https://www.coherentmarketinsights.com/market-insight/hand-tools-market-3807)

ABOUT TOUGHBUILT INDUSTRIES, INC:

ToughBuilt is an advanced product design, manufacturer and distributor with emphasis on innovative products. Currently, we are focused on tools and other accessories for the professional and do-it-yourself construction industries. We market and distribute various home improvement and construction product lines for both the do-it-yourself and professional markets under the TOUGHBUILT brand name, within the global multibillion dollar per year tool market industry. All of our products are designed by our in-house design team. Since launching product sales in 2013, we have experienced significant annual sales growth. Our current product line includes three major categories, with several additional categories in various stages of development, consisting of Soft Goods & Kneepads and Sawhorses & Work Products. Our mission is to provide products to the building and home improvement communities that are innovative, of superior quality derived in part from enlightened creativity for our end users while enhancing performance, improving well-being and building high brand loyalty. Additional information about the Company is available at: https://www.toughbuilt.com/.

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the impact of the worldwide COVID-19 pandemic and government actions, on our business, (ii) supply chain disruptions, (iii) market acceptance of our existing and new products, (iv) delays in bringing products to key markets, (v) an inability to secure regulatory approvals for the ability to sell our products in certain markets, (vi) intense competition in the industry from much larger, multinational companies, (v) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) our reliance on single suppliers for certain product components, (xi) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Relations Contact:

KCSA Strategic Communications

David Hanover


[email protected]

 



KidKraft® Partners With American Girl® to Debut New Luxe Dollhouse and Custom Closet for the Beloved Brand’s Signature 18-Inch Dolls

KidKraft® Partners With American Girl® to Debut New Luxe Dollhouse and Custom Closet for the Beloved Brand’s Signature 18-Inch Dolls

Ultimate tri-level stands 4½ feet tall and offers endless hours of imaginative play

DALLAS–(BUSINESS WIRE)–
KidKraft®, a premium wood toy and furniture brand crafted to inspire imaginative and active indoor and outdoor play, announces an exciting new product collaboration with American Girl®, the popular lifestyle brand for girls. Available now and just in time for the holidays, the first officially licensed American Girl dollhouse and add-on magic closet is built of premium wood materials and sized just right for fans of American Girl’s popular 18-inch dolls.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221004006163/en/

KidKraft® partners with American Girl® to debut new luxe dollhouse for the beloved brand's signature 18-inch dolls (Photo: Business Wire)

KidKraft® partners with American Girl® to debut new luxe dollhouse for the beloved brand’s signature 18-inch dolls (Photo: Business Wire)

Designed to inspire endless hours of imaginative play, the two impressive-sized items—the American Girl® x KidKraft® Luxury Dollhouse and the American Girl® x KidKraft® Custom Closet—have nine play areas to discover and numerous amenities, including a spinning ceiling fan, working lights, secret storage, and more.

“KidKraft is known for our collection of beautifully crafted wooden dollhouses which help to aid and inspire imaginative play for children of all ages,” said Susan Russo, VP of Product & Brand Marketing for KidKraft. “With our commitment to delivering imaginative play experiences and American Girl’s decades-long history of empowering girls through storytelling, a joining of forces was a natural fit.”

The American Girl x KidKraft collection is available now at AmericanGirl.com and at American Girl retail stores and includes:

American Girl® x KidKraft® Luxury Dollhouse for 18-inch Dolls – $598.00

  • Offering countless hours of 360° play, this jaw-dropping 4½ feet tall and 5 feet wide ultimate dollhouse has a cool tri-level layout, designed with all the comforts of home and several dream amenities.
  • Features include a high-tech security system, a fireplace that glows and crackles, a ceiling fan that lights up and spins, a shower that changes color with the “temperature”, and a lights-and-sounds hot tub that fits four dolls.
  • Built-in fixtures and décor include a pet door, open-and-close windows, swivel pretend TV, glittery curtains and secret storage.

American Girl® x KidKraft® Custom Closet for 18-inch Dolls – $298.00

  • Boasting two stories with a grand spiral staircase, this more than 3½-foot-tall fashion changing room has an innovative virtual “try-on” experience for dolls. A magic mirror showcases a total of four outfit choices, illuminating them right onto the doll!
  • Tons of storage options for clothes and accessories keeps everything organized and ready for dress up.
  • Can stand alone or be an add-on to the luxury dollhouse for extended play. Stairs are moveable to different areas of the house.

The partnership between American Girl and KidKraft brings together two likeminded premium brands that are committed to nurturing a child’s creativity and imagination. The high-quality dollhouse—with its numerous play areas, functionality, and large, open spaces for additional add-ons like furniture, beds, and clothing—expands the play experience and offers a lifetime of value and fun.

For more information on the American Girl® x KidKraft collection, please visit AmericanGirl.com. Receive the latest updates by following KidKraft on Instagram, YouTube, and Facebook.

ABOUT KIDKRAFT, INC

KidKraft is a global leader in award-winning children’s products Made for Make Believe™. For over 50 years, KidKraft has been crafting toys and furniture to amplify and enrich childhood through destinations for playing, exploring and living. Crafted of premium, recyclable materials for long-lasting play, KidKraft’s indoor and outdoor products are available at more than 2,800 retailers in over 90 countries. KidKraft’s global headquarters is located in Dallas, Texas. For more information, visit www.kidkraft.com and follow @kidkrafttoys and #KidKraftToys on Instagram.

ABOUT AMERICAN GIRL

American Girl® is a premium brand for girls and a wholly-owned subsidiary of Mattel, Inc. (NASDAQ:MAT, www.mattel.com), a leading global toy company and owner of one of the strongest catalogs of children’s and family entertainment franchises in the world. Headquartered in Middleton, WI, American Girl offers an inspiring world of dolls, content, and experiences that nourish a girl’s spirit and help develop her strength of character. Best-selling lines include Truly Me™, Girl of the Year™, Bitty Baby®, WellieWishers™, Create Your Own, and American Girl’s classic historical characters. The company sells products through its award-winning catalogue, on americangirl.com, in its proprietary U.S. experiential retail stores, as well as at specialty retailers nationwide. By inspiring girls to be their best, American Girl has earned the loyalty of millions and the praise and trust of parents and educators. Connect with American Girl on:

Facebook: @americangirl

Twitter: @American_Girl

Instagram: @americangirlbrand

Pinterest: agofficial

YouTube: American Girl

Catalina Ramirez

Litzky Public Relations

(201) 222-9118

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Parenting Children Other Retail Toys Specialty Family Lifestyle Consumer Retail Online Retail

MEDIA:

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KidKraft® partners with American Girl® to debut new custom closet for the beloved brand’s signature 18-inch dolls (Photo: Business Wire)
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KidKraft® partners with American Girl® to debut new luxe dollhouse for the beloved brand’s signature 18-inch dolls (Photo: Business Wire)

Mirum Pharmaceuticals to Present LIVMARLI® (maralixibat) Analyses and Host a Scientific Symposium at NASPGHAN 2022 Annual Meeting

Mirum Pharmaceuticals to Present LIVMARLI® (maralixibat) Analyses and Host a Scientific Symposium at NASPGHAN 2022 Annual Meeting

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will present three posters and host a scientific symposium during the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place October 12-16, 2022, in Orlando, Florida.

Analyses Presented During the Congress

Poster #290: Maralixibat Improves Growth in Patients with Alagille Syndrome: A 4-Year Analysis (p. 210)

Friday, October 14, 2022 from 12:00-2:30pm ET, Poster Session II

Presented by: Binita M. Kamath, MBBChir, The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada

Poster #291: Maralixibat-Treated Patients with Alagille Syndrome Demonstrate Improved Event-Free Survival in a Natural History Comparison with Patients from the GALA Database: Application of Real-World Evidence Analytics (p. 291)

Friday, October 14, 2022 from 12:00-2:30pm ET, Poster Session II

Presented by: Binita M. Kamath, MBBChir, The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada

Poster #552: Caregiver Burden Associated with Caring for a Child with Alagille Syndrome: A Multi-National Quantitative Analysis (p.403)

Saturday, October 15, 2022 from 12:00-2:30pm ET

Presented by: Robin Howard, Mirum Pharmaceuticals, Inc.

The abstracts are now available via the NASPGHAN website and full presentations will be available upon presentation at the congress, which starts on October 12.

Scientific Symposium

Mirum will host a scientific symposium, “Beyond Itch: Exploring the Clinical Benefits of Treating Cholestasis in Children,” featuring Drs. William F. Balistreri (chair), Binita M. Kamath, Regino P. Gonzalez-Peralta, and Saeed Mohammad.

The event will take place on Thursday, October 13, 2022 from 7:15-8:45pm ET in Sebastian L 1/2.

About LIVMARLI® (maralixibat) oral solution

LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older and is the only FDA-approved medication to treat cholestatic pruritus associated with Alagille syndrome. For more information, please visit LIVMARLI.com.

LIVMARLI is currently being evaluated in late-stage clinical studies in other rare cholestatic liver diseases including progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS, PFIC and biliary atresia. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirum’s clinical trials section on the company’s website.

IMPORTANT SAFETY INFORMATION

LIVMARLI can cause side effects, including:

Changes in liver tests. Changes in certain liver tests are common in patients with Alagille syndrome and can worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your healthcare provider should do blood tests before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen) or loss of appetite.

Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea, stomach pain, and vomiting during treatment. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you.

A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat. FSV deficiency is common in patients with Alagille syndrome but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment.

Other common side effects reported during treatment were bone fractures and gastrointestinal bleeding.

Prescribing Information

About Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. Please view the warnings and precautions available in the Prescribing information or, for more information, visit LIVMARLI.com.

Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open across multiple countries for eligible patients with ALGS and PFIC.

Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome.

Mirum’s second investigational treatment, volixibat, an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the VISTAS Phase 2b clinical trial for adults with primary sclerosing cholangitis, the OHANA Phase 2b clinical trial for pregnant women with intrahepatic cholestasis of pregnancy, and the VANTAGE Phase 2b clinical trial for adults with primary biliary cholangitis.

Learn more about Mirum by visiting www.mirumpharma.com. Follow Mirum on Twitter, Facebook, LinkedIn and Instagram.

Forward-Looking Statements

This press release includes forward-looking statements or efficacy statements pertaining to the Company’s planned participation at a scientific conference, including data presentation title and synopsis, which may include discussion of the Company’s clinical and research data, including the discovery, development and commercialization of our product candidates and technologies, and the therapeutic potential thereof, the continuation of our clinical trials, and the success of our collaborations with partners and any potential future collaborations. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those relating to our preclinical research and clinical programs and other risks identified under the heading “Risk Factors” included in our most recent Form 10-Q and Form 10-K filings and in other future filings with the SEC. The forward-looking statements contained in this press release reflect Mirum’s current views with respect to future events, and Mirum does not undertake and specifically disclaims any obligation to update any forward-looking statements, except as required by law.

Media Contact:

Erin Murphy

[email protected]

Investor Contacts:

Ian Clements, Ph.D.

[email protected]

Sam Martin

Argot Partners

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

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